The present invention relates generally to a system and method for suturing first and second tissue sections, and more specifically to an anastomosis system and method particularly useful in minimally invasive procedures.
The vast majority of surgical procedures require suturing of first and second tissue sections. This suturing can be time consuming. Additionally, if a laparoscopic or otherwise minimally invasive approach is used, accurate suture placement can be both time consuming and difficult to achieve.
Despite these concerns, minimally invasive surgical and interventional procedures have become widespread. Many of these procedures require anastomosis, i.e. connection of hollow structures. For example, radical prostatectomy, the complete surgical removal of the prostate gland as a treatment for prostate cancer, entails the removal of the prostate gland along with its fascial coverings and requires amputating the junctions of the prostate to the urethra at the urogenital diaphragm and to the urinary bladder at the bladder neck. To restore continuity of the urinary tract where the prostate has been removed, a new connection (anastomosis) of the bladder neck to the urethra must be accomplished.
This is the most challenging part of the radical prostatectomy procedure. The difficulty lies in placing a needle and suture at the correct angle and with the correct amount of tissue thickness to accomplish a secure and accurate connection. This is especially true in the case of the laparascopic radical prostatectomy where the entire operation is performed through multiple small puncture sites in the abdominal wall fascia using fiber-optic visualization and a variety of tubular small diameter ( less than 15 mm) working ports. During laparascopic radical prostatectomy, the correct placement of a minimum of four stitches to complete this anastomosis can take more than an hour.
Therefore, a need exists for a system and method for quickly and accurately suturing first and second tissue sections in anastomosis and other procedures.
The present invention relates to a suturing system and method for suturing first and second tissue sections. The system includes an elongate member having paired first distal and proximal channels for receiving portions of a first suture. The first distal channel extends in the elongate member from the proximal end to a first distal aperture and receives the distal end portion and at least a part of the body portion of the first suture. The first proximal channel extends in the elongate member from the proximal end to a first proximal aperture and receives the proximal end portion and at least a part of the body portion of the first suture. The elongate member is moved between the first and second tissue sections as required to achieve the optimum entry position for each needle. The first proximal aperture is at a distance from the first distal aperture and the device is manipulated so that the distal end of the first suture passes through the first tissue section and the proximal end of the first suture passes through the second tissue section.
The elongate member can include indicia on an outer surface for providing reference markings for positioning the elongate member. The distal end of the elongate member can be provided with a flexible tip to facilitate insertion. The flexible tip can be integral to the elongate member or the distal end of the elongate member can have a threaded stud for attaching the flexible tip. In one embodiment, the first distal channel has a curved section leading to the first distal aperture. The first proximal channel can also have a curved section leading to the first proximal aperture.
The distal and proximal end portions of the first suture each can have a needle attached thereto to facilitate passage through tissue. In this regard, the system can also include a needle pusher for advancing or withdrawing one of the needles through the first distal or proximal channel. The needles are made of a material having elasticity to allow the needles to bend through the curved section of either the first distal or proximal channel and then straighten partially or completely after passing therethrough. A shape memory material, for example, a nickel titanium alloy or the like, is such a material. In one embodiment, each of the needles has a radius and can recover to being substantially straight after having been bent to as small as about eight times the needle radius.
In order to allow suture removal from the channels, the elongate member will be made as a multi-component piece. For example, the elongate member can include a central longitudinal section in which the first distal and proximal channels extend and a first outer longitudinal section mating with the central longitudinal section. Each of the channels has a side open to the exterior of the central longitudinal section and the first outer longitudinal section covers the open side of the first distal and proximal channels.
Other paired channels can be provided in the elongate member to accommodate additional sutures. For example, the elongate member can include a second distal channel extending in the elongate member from the proximal end to a second distal aperture and configured and dimensioned to receive the distal end portion and at least a part of the body portion of the second suture; and a second proximal channel extending in the elongate member from the proximal end to a second proximal aperture and configured and dimensioned to receive the proximal end portion and at least a part of the body portion of the second suture. When the elongate member is positioned through the first and second tissue sections with the second needle and suture in the second distal and second proximal channels such that a part of the body portion extends from the proximal end of the elongate member, the distal end of the second suture may be passed through the first tissue section and then the proximal end of the second suture can be positioned so that the proximal needle passes through the second tissue section. As a result, the second suture passes through both the first and second tissue sections.
In order to cover both the first and second set of paired channels, the elongate member can comprise a central longitudinal section in which the first distal and proximal channels and the second distal and proximal channels extend (each of the channels having a side open to the exterior of the central longitudinal section), a first outer longitudinal section mating with the central longitudinal section to cover the open side of the first distal and proximal channels, and a second outer longitudinal section mating with the central longitudinal section to cover the open side of the second distal and proximal channels.
In one embodiment, the central longitudinal section has first and second alignment bores and each of the first and second outer longitudinal sections has an alignment prong. The alignment prong of the first outer longitudinal section is insertable in the first alignment bore and the alignment prong of the second outer longitudinal section is insertable in the second alignment bore to mate the central and first and second longitudinal sections. One or more flexible rings can be used to fasten together the central and first and second longitudinal sections.
The present invention allows for the quick and efficient placement of needles and sutures. This is beneficial as it makes it technically easier and reduces errors in placing needles and sutures during surgery and decreases the amount of time required to perform the essential repair of the urethra, in the case of radical prostatectomy, or other difficult suturing operations. The foregoing and other features of the present invention will be apparent from the following more particular description of embodiments of the invention, as illustrated in the accompanying drawings.